LEVITRA can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. With a sudden drop in blood pressure, you could get dizzy, faint, or have a heart attack or stroke.

About ED

Almost all men, at some time in their lives, have occasional difficulty getting and keeping an erection.

With ED, a man's erection is characterized by:

The inability of the penis to harden and expand when the man is sexually excited

The inability to keep an erection

It is estimated that up to 30 million men in the United States have experienced at least some degree of ED.

If you've noticed changes in your erections, there is something you can do about it - Talk to Your Doctor.

Indication
LEVITRA is a prescription medicine used for the treatment of erectile dysfunction (ED) in men.

Important Safety Information

LEVITRA can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. With a sudden drop in blood pressure, you could get dizzy, faint, or have a heart attack or stroke.

Do not take LEVITRA if you:

Take any medications called "nitrates" (often used to control chest pain, also known as angina), or if you use recreational drugs called "poppers" like amyl nitrate and butyl nitrate. Nitrates may cause abnormally low blood pressure and LEVITRA may increase that risk.

Have been told by your healthcare provider not to have sexual activity because of health problems. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease.

Tell all your healthcare providers that you take LEVITRA. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took LEVITRA.

LEVITRA does not protect a man or his partner from sexually transmitted diseases, including HIV.

Before taking LEVITRA, tell your doctor about all your medical problems, including if you:

have heart problems such as angina, heart failure, irregular heartbeats, or have had a heart attack—ask your doctor if it is safe for you to have sexual activity

have low blood pressure or have high blood pressure that is not controlled

have had a stroke

have had a seizure

or any family members have a rare heart condition known as prolongation of the QT interval (long QT syndrome)

have ever had severe vision loss, or if you have an eye condition called non-arteritic anterior ischemic optic neuropathy (NAION)

have stomach ulcers

have a bleeding problem

have a deformed penis shape or Peyronie's disease

have had an erection that lasted more than 4 hours

have blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia

have hearing problems

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. LEVITRA and other medicines may affect each other. Especially tell your doctor if you take any of the following:

Medicines called alpha-blockers. These include Hytrin® (terazosin HCl), Flomax® (tamsulosin HCl), Cardura® (doxazosin mesylate), Minipress® (prazosin HCl), Uroxatral® (alfuzosin HCl), or Rapaflo® (silodosin). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients the use of PDE5 inhibitor drugs, including LEVITRA, with alpha-blockers can lower blood pressure significantly, leading to fainting. You should contact the prescribing physician if alpha-blockers or other drugs that lower blood pressure are prescribed by another healthcare provider

Tell your doctor if you take alpha-blockers. These include Hytrin® (terazosin HCl), Flomax® (tamsulosin HCl), Cardura® (doxazosin mesylate), Minipress® (prazosin HCl), Uroxatral® (alfuzosin HCl), or Rapaflo® (silodosin). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients the use of PDE5 inhibitor drugs, including LEVITRA, with alpha-blockers can lower blood pressure significantly, leading to fainting.

Contact the prescribing physician if alpha-blockers or other drugs that lower blood pressure are prescribed by another healthcare provider

Tell your doctor if you take medicines that treat abnormal heartbeat. These include quinidine, procainamide, amiodarone, and sotalol. Patients taking these drugs should not use LEVITRA.

Do not use LEVITRA with other medicines or treatments for ED.

Take LEVITRA exactly as your doctor prescribes. LEVITRA comes in different doses (2.5 mg, 5 mg, 10 mg, and 20 mg). For most men, the recommended starting dose is 10 mg. Do not take more than one tablet of LEVITRA per day. Doses should be taken at least 24 hours apart. Some men can take only a low dose of LEVITRA because of medical conditions or medicines they take. Your doctor will prescribe the dose that is right for you

If you are older than 65 or have liver problems, your doctor may start you on a lower dose of LEVITRA

If you have prostate problems or high blood pressure for which you take medicines called alpha-blockers, your doctor may start you on a lower dose of LEVITRA

If you are taking certain other medicines your doctor may prescribe a lower starting dose and limit you to one dose of LEVITRA in a 72-hour (3 days) period.

The most common side effects with LEVITRA are headache, flushing, stuffy or runny nose, indigestion, upset stomach, dizziness, and back pain.

LEVITRA may uncommonly cause:

An erection that lasts more than 4 hours. Get medical help right away to avoid lasting damage to your penis

Color vision changes, such as seeing a blue tinge to objects or having difficulty telling the difference between the colors blue and green

In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines, including LEVITRA) reported a sudden decrease or loss of vision in one or both eyes or a sudden decrease or loss in hearing, sometimes with ringing in the ears and dizziness. It is not possible to determine whether these events are related directly to the PDE5 inhibitors, to other diseases or medications, to other factors, or to a combination of factors. If you experience sudden decrease or loss of vision or hearing, stop taking LEVITRA and contact a doctor right away.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.